MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. PERCUTANEOUS SHEATH / INTRODUCER KIT W/ INTEFRAL HEMOSTASIS VALE / SIDE PORT FOR; INTRODUCER, CATHETER

Model Number AK-09903-CDC

Device Problems Difficult to Remove (1528); Unraveled Material (1664); Physical Resistance/Sticking (4012)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/05/2019

Event Type  Injury  

Event Description

Anesthesiologist used steeper angle and got good blood flow in the ij.Wire threaded easily.Ultrasound showing wire in ij.Then crna threaded the cordis over the wire with slight resistance.Upon trying to remove the wire from the introducer, the wire was unraveling.There was little resistance but it kept unraveling as it was pulled out.Since the wire unraveled there was concern that a part of the wire could still be intravascular.Ultrasound was used to look at the vessel.No district signs of the wire but there was something flapping in the vessel which may be a vascular injury.No hematoma in the neck and vessel looks overall intact.Discussed case with cv surgeon and ir.Decision made to do a ct of the chest and neck, introducer was sutured in place, ct revealed retained guidewire and decision made for ir procedure to remove wire.Fda safety report id# (b)(4).

• Brand Name: PERCUTANEOUS SHEATH / INTRODUCER KIT W/ INTEFRAL HEMOSTASIS VALE / SIDE PORT FOR
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL, INC.
• MDR Report Key: 8735248
• MDR Text Key: 149467687
• Report Number: MW5087615
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10801902117417
• UDI-Public: (01)10801902117417
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AK-09903-CDC
• Device Catalogue Number: AK-09903-CDC
• Device Lot Number: 13F19A0303
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization